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Quality manager jobs in Fort Wayne, IN - 73 jobs

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  • Quality Manager

    Holder Construction 4.7company rating

    Quality manager job in Fort Wayne, IN

    Holder Construction, an Atlanta-based commercial construction company with operations throughout the United States, is seeking a highly motivated management professional to join our project team in Ft. Wayne, IN. This position works within the team to ensure overall project quality and the performance of daily quality procedures to provide proper coordination and documentation to meet the project standards and requirements. The position will work directly with operations, clients/owners, designers, and third-party agents to manage the complex quality trade and processes. Primary Responsibilities Ability to work and communicate effectively with the project team, subcontractors, consultants, and owner representatives. Execute inspections with trade partners to oversee checklist and accuracy before and after inspection. Work with trade partners to ensure documentation is completed and work is installed to a high standard of quality per the project documents, in support of the project schedule. Review installations and all mockups with the owner, client, and architect. Understand all quality processes, procedures, expectations, and the utilization of tools to ensure project success. Ability to read and understand construction plans and specifications including identification of errors or redundancies for resolution by others. Provide leadership & willingness to take ownership of trade management for yourself and other QA/QC Engineers Oversee the quality team, and support any documentation and office-based responsibilities to meet construction schedule and specific QA/QC programs. oEngage in the submittal review process ahead of installation to identify quality concerns and ways to increase quality assurance. oEngage with O/A/Es & continuously to understand project goals and track the strategies to meet and exceed them. Complete daily field walks with the field team to ensure quality assurance. Regularly review scope installation progress with the field team to ensure quality assurance. oCoordinate resolution for all systems/tools, data entry, tracking tools, Completion List, Punchlist, NCR, Observations Deficiency Logs, along with other designated software, and provide documentation of all meeting minutes. Familiarity with a broad range of general construction processes and nomenclature including testing laboratory protocols and procedures. Coordinate with trade partners for inspection paperwork, manage and train the team on software tools required to manage and execute the quality program. Create, document and distribute all checklists, inspections, completion lists, punch lists, and reports on the office side. Communicate to facilitate field activities required for issue completion, along with issue durations and due dates with trade partners. oWork with both office and field staff to understand the project schedule in order to execute the inspection process to support critical commissioning and energization dates. Participate in Trade pre-installation meetings to verify that each Trade has an understanding of the Project's QC requirements before beginning work on site. Requirements For This Position Include 3-5 years of management or field construction-focused experience on projects similar in nature, size, and extent. Bachelor's degree in construction management, engineering, or equivalent combination of training and experience. Proficient in MS-based software including Word, Excel, Outlook, Bluebeam, BIM360, Field, SmartSheet, etc. Proficient with QA/QC systems, platforms, and technologies that allow for tracking, metrics and reporting.
    $75k-94k yearly est. 4d ago
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  • Director, Parenteral Sterility Assurance

    Eli Lilly and Company 4.6company rating

    Quality manager job in Gas City, IN

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: Assess differences in current sterility assurance programs across the sites and drive harmonization Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. Building, maintaining, and growing capability across the organization in the sterility assurance space Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: BS Degree required. MS/PhD in a biological science preferred. 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities Strong written and oral communication skills Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. Support the establishment of a sterility assurance network or hub in global TSMS Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. Strong capability to influence personnel and management across the organization Close interaction with quality to enable internal audits that identify risks Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $133.5k-246.4k yearly Auto-Apply 60d+ ago
  • Senior Manager, Quality Assurance

    Co-Us Ducharme, McMillen & Associates

    Quality manager job in Fort Wayne, IN

    As an employee-owned company, DMA prioritizes employees. Low turnover rates and tenured teams are living proof: 2025 Great Places to Work Certified Employee stock ownership program eligibility begins on day one of employment (ESOP contribution is targeted at 6% of your annual compensation) Company paid parental leave Generous time off package Multiple benefit plans, eligibility begins on day one of employment Culturally focused on work/life balance, mental health, and the overall wellness of our employees This is a hybrid position with an expectation to be in our Fort Wayne, IN office a minimum of two days per week. This position does not qualify for relocation assistance. Must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. This position does not qualify for employment-based sponsorship. Position Summary The Senior Manager, Quality Assurance leads the strategic direction and execution of DMA's QA practice. This role oversees quality assurance operations, testing methodologies, automation strategies, and team development. The Senior Manager ensures that software releases meet functional and technical requirements, supports agile delivery, and drives continuous improvement across QA processes and tools. Essential Duties and Responsibilities • Oversee QA operations and software delivery quality across multiple projects and teams. • Develop and execute testing strategies, plans, estimates, and schedules for product releases. • Track milestones; prepare regular progress reports; monitor budgets, receipts and expenditures related to projects; communicate with the executive team and other stakeholders. • Demonstrate leadership abilities to our clients with the deployment of software upgrades, enhancements and fixes that are coordinated based on release schedules. • Lead and mentor QA managers and engineers to achieve high performance and career growth. • Manage talent acquisition and succession planning for the QA team. • Champion department and corporate initiatives related to quality, automation, and process improvement. • Collaborate with product owners, subject matter experts, and clients to define testable requirements. • Coordinate and participate in sprint planning, release readiness, and regression testing cycles. • Define and implement automated unit and regression test cases. • Ensure proper documentation of QA processes, test plans, and results. • Facilitate communication across distributed teams to optimize resource utilization. • Provide regular quality status reports to leadership and stakeholders. • Establish and maintain relationships with third-party software vendors. • Divide tasks into quantifiable subtasks, and reasonably predict the effort to complete the tasks. • Ensure compliance with security, performance, and quality standards. • Identify, manage, and mitigate technical and operational risks. • Management and oversight of direct reports. • Track actual hours against estimates, anticipate, and communicate deviations from original estimates to all stakeholders. Work with team members to ensure that software releases meet the defined security and quality assurance standards. Education and Qualifications · Bachelor's degree in Computer Science, Information Technology, or related field. · Minimum of 8+ years experience in software QA. · Minimum of 3+ years in a QA leadership role. · Proven success in developing and executing testing strategies and automation frameworks. · Strong understanding of Quality Assurance, Quality Control, and SDLC. · Technical proficiency in SQL, relational databases, distributed systems, web-based architecture, and batch processing. · Experience with automated testing tools, CI/CD pipelines, and performance testing. · Experience with agile methodologies, SCRUM, the SDLC, and DevOps practices. · Proficiency in tools such as Chrome, GitLab, Atlassian Jira, and automation frameworks. · Excellent problem-solving, organizational, and multitasking skills. · Strong verbal and written communication abilities. · Ability to lead under tight project timelines and shifting priorities. · Ability to delegate effectively and motivate others. · Flexible and able to adapt to changing priorities. · Strong listening skills; trustworthy and dependable. · Excellent leadership skills. #LI-JS1 #LI-HYBRID The Company is an equal employment opportunity employer and is committed to providing equal employment opportunities to its applicants and employees. The Company does not discriminate in employment opportunities or practices on the basis of race, color, religion, gender, national origin, citizenship, age, disability, veteran status, genetic information, or any other category covered by applicable federal, state, or local law. This equal employment opportunity policy applies to all employment policies, procedures, and practices, including but not limited to hiring, promotion, compensation, training, benefits, work assignments, discipline, termination, and all other terms and conditions of employment. It is DMA's policy to make reasonable accommodations for qualified individuals with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please contact our Human Resources team at *********************** or ************ and choosing selection 6.
    $92k-139k yearly est. Auto-Apply 45d ago
  • Quality Assurance Manager

    Maximus 4.3company rating

    Quality manager job in Fort Wayne, IN

    Description & Requirements Maximus is currently hiring for a Quality Assurance Manager to support our Missouri Enrollment Broker project. This is a full time remote opportunity. The Quality Manager is responsible for overseeing the daily operations for the Quality Assurance team, and for creating efficient business partnerships to meet business goals. The project will be a multi-channel contact center that will support multiple clients throughout the state of Missouri. *This job is contingent upon contract award.* At Maximus we offer a wide range of benefits to include: - • Competitive Compensation - Quarterly bonuses based on performance included! - • Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance. - • Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching. - • Unlimited Time Off Package - Enjoy UTO, Holidays, and sick leave, - • Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP). - • Recognition Platform - Acknowledge and appreciate outstanding employee contributions. - • Tuition Reimbursement - Invest in your ongoing education and development. - • Employee Perks and Discounts - Additional benefits and discounts exclusively for employees. - • Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs. - • Professional Development Opportunities- Participate in training programs, workshops, and conferences. Essential Duties and Responsibilities: - Oversee the day-to-day functions of the Quality Assurance (QA) department. - Manage an effective quality assurance program that monitors and resolves issues before they become problems. - Supervise the development and regular update of policies and procedures. - Evaluate the need for and ensure the provision of necessary training for project personnel, providing up-to-date information on relevant programs, community resources, and options for consumers. - Arrange staff training on a regular and ongoing basis. Ensure project training program meets all corporate requirements. - Provide project leadership with updates on all issues regarding quality, operations, training, and policy and procedures. - Provide leadership to all staff in the areas of quality improvement as it relates to process improvement, customer service and conflict resolution. - Prepare reports and briefings for project leadership and review monthly and quarterly project status reports provided to the Department. Minimum Requirements - Bachelor's degree in relevant field of study and 5+ years of relevant professional experience required, or equivalent combination of education and experience. - Must be willing and able to travel up to 25% of the time as business need dictates. - Lean Six Sigma experience with a minimum of Yellow Belt Certification required. - Experience managing direct reports remotely required. - Experience with designing, implementing and reporting customer satisfaction surveys required. - Experience with standardized quality tools required. - Experience with call and voice monitoring platforms required. - Experience with a large-scale telephony system required. - Experience with Client Relationship Management (CRM) platforms required. - Experience with contract compliance and quality platforms required. - Experience with statistical processes required. - Premium contact center billing experience required. - Financial experience with Oracle preferred. Home Office Requirements: - Internet speed of 20mbps or higher required (you can test this by going to ******************* - Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router. - Must currently and permanently reside in the Continental US. #max Priority #LI-Remote EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************. Minimum Salary $ 80,000.00 Maximum Salary $ 95,000.00
    $67k-96k yearly est. Easy Apply 2d ago
  • Quality Manager

    Forest River 4.3company rating

    Quality manager job in Goshen, IN

    Forest River, Inc., the Nation's largest manufacturer of Recreational Vehicles, Cargo Trailers, Transit Buses and Boats has an immediate opening. Responsibilities Full Inspection of Inside and Outside of Units Qualifications Experience in the RV Industry Strong People Skills Code Knowledge is a Plus Excellent Attendance a must Forest River offers a stable work environment that is fast paced. Our employees enjoy a highly competitive Wage and Benefit Package. We are looking for dedicated individuals with experience in the Industry as well as other Manufacturing Processes.
    $80k-104k yearly est. 8d ago
  • Bank Quality Control Manager

    Sb Financial Group, Inc. 4.0company rating

    Quality manager job in Defiance, OH

    **SIGNING BONUS AVAILABLE FOR A LIMITED TIME! APPLY TODAY!** State Bank, a growing Community Bank, has an opportunity for a self-motivated and leadership-minded individual to join and lead our team of Quality Control Analysts. We are seeking a Full Time Quality Control Manager. This position is responsible for leading our Quality Control Analysts Group in order to establish advanced quality controls and to implement continuous improvement standards and procedures for State Bank. A B.S. or B.A. or equivalent preferred, or experience in lieu of degree; Mortgage Lending, HMDA and Quality Control training or practical experience. Experience in mortgage and commercial lending or related positions required. Consumer, SBA, and Retail banking deposit experience preferred. State Bank offers an extensive benefits package including paid vacation and PTO, medical/dental/vision insurance, company-paid life and AD&D insurance, a company-matched 401(k) retirement plan, company-provided short and long-term disability, quarterly incentive payouts, a community volunteer program, and growth opportunities. Apply today and see why State Bank is a great place to work! Equal Opportunity Employer
    $90k-116k yearly est. Auto-Apply 60d+ ago
  • Food Safety Quality Assurance Supervisor

    Cafe Valley Bakery 4.3company rating

    Quality manager job in Marion, IN

    Job DescriptionThe FSQA Supervisor oversees Quality Lab functions to ensure compliance with all Company, industry, quality, food safety, and regulatory guidelines, such as HACCP (Hazard Analysis Critical Control Points), GMP (Good Manufacturing Practices), SPC (Statistical Process Control), and Standard Operating Procedures (SOP's) in support of the plant's Quality Assurance & Food Safety. Develop and maintain clear objectives for FSQA lab techs within the department under the supervisor's influence and control. Monitor KPI's for achieving results while fostering a safe working environment. Provide training and coaching which will allow each associate to perform at their best and deliver results in a continuous process improvement environment. Ensure all associates understand the vision of our company.Responsibilities Consistent and dependable attendance. Ability to work overtime, weekends and flexible schedules as business needs demand. Must be able to work within a team environment, treat all with respect - no fighting. Ability to work with or around food allergens of all types. Must have the ability to stand a minimum of 6 hours without a break and a maximum of 12 hours with a break. There are NO sitting positions or jobs. Must be able to wear/utilize personal protective equipment. Ability to work in confined spaces. (Spiral, oven area, etc) Ability to climb up and down ladders and traverse walkways. Helps FSQA Manager enforce the Company's GMP, Quality and Food Safety policies and procedures. Directly supervises the FSQA Technicians to ensure they are fully trained to successfully understand and perform job duties associated with the FSQA Technicians role. Performs investigations for customer complaints. Conduct Root Cause Analysis and risk assessments. Able to perform “Hazard Analysis and Risk-Based Preventive Controls” for new products or processes. Able to communicate any new procedures to the Leadership Team, FSQA Team as well as Operations Teams in FSQA Managers absence. Train each FSQA to have a clear understanding of risk based preventative controls. Schedules of all the FSQA Technicians. Carry-out weekly environmental swabbing, ensuring swabs are sent received by the lab. Maintain all EMP records using the EMP program. Schedule all EMP work with the technicians Verify that all quality checks are correctly carried out and completed. This will include completion of any and all tasks not in Red zone. Ensure all testing equipment is calibrated per SOP. Train all FSQA Technicians to complete all documentation regarding Holds, in- house testing, Flour sifter, Truck inspection (oil, flour) and any other documents not in Red Zone and upload into shared drive weekly. Ensure FSQA tech properly complete retentions storage, shelf life testing, moisture testing and any other quality function that is assigned to ensure the quality and integrity of the products. Keep an inventory of all laboratory supplies and re-order as necessary. Help his /her Manager update and maintain all BRC compliance documentation. Complete and verify daily staff ADP cards. Work with his/her Manager on monthly food safety inspections and any corrective action needed. Preform traceability, reverse tractability, and mock recalls monthly. Uploading the reports to the shared drive. Carry out any non- standard duties as assigned by his/her Manager. Ensure FSQA tech properly complete retentions storage, shelf life testing, moisture testing and any other quality function that is assigned to ensure the quality and integrity of the products. Required SkillsQualifications required: Bachelor's degree in Food Science, or a minimum of 5 years of Food Manufacturing Quality Assurance experience is required. HACCP Certified PCQI certified Strong knowledge of industry's best practices for food safety, cGMP's, quality, and regulatory requirements Ability to speak, read and write in English. Qualifications desired: Bilingual (English/Spanish) A working knowledge of food safety regulations; good communication skills and able to manage and train staff to maintain the high-quality standards in the facility.
    $58k-76k yearly est. 5d ago
  • Quality Control Assistant Manager

    Pro Resources Staffing Services 3.9company rating

    Quality manager job in Berne, IN

    Now Hiring through Pro Resources - Quality Control Assistant Manager Berne, IN | 1st Shift | Direct Hire $60,000-$70,000 Salary + Full Benefits Pro Resources is proud to partner with a leading automotive manufacturer in Berne, Indiana, to find a driven and detail-focused Quality Control Assistant Manager for a direct hire opportunity on 1st shift. This is a fantastic career opportunity for someone with strong leadership skills and a passion for quality management. If you're ready to take the next step in your career and help shape the future of a growing company, we want to hear from you! Responsibilities Include: Support development and execution of the QC department's business plan Assist QC supervisors with daily operations and compliance tracking Lead and mentor team members to promote growth and development Conduct internal non-conformance investigations and Gemba walks Complete customer quality reports (8D, capability studies, etc.) Communicate with customers and suppliers on quality-related issues Review and approve abnormal tags, sorts, and gauge validations Oversee technical support for QA machines and gauges Ensure compliance with IATF 16949 and ISO 14001 standards Maintain a positive work environment focused on excellence and teamwork What We're Looking For: Bachelor's degree in industrial technology, metrology, or related field (or equivalent experience) 5+ years in automotive manufacturing or a related industry Six Sigma Green Belt or CQE certification preferred Experience with problem-solving tools like 8D, 5-Why, and Six Sigma Strong knowledge of SPC, MSA, PFMEA, control plans, Minitab, Excel, and PowerPoint Effective communicator with strong leadership and technical writing skills Position Highlights: Direct hire through Pro Resources Competitive salary range: $60,000-$70,000 annually Full benefits package First shift hours with long-term stability Opportunity to grow your career with a reputable manufacturer If you're ready to make an impact and grow your career, apply today through Pro Resources! #clerical
    $60k-70k yearly 60d+ ago
  • Quality Engineer

    Dana Corporation 4.8company rating

    Quality manager job in Fort Wayne, IN

    Job Purpose The Quality Engineer is responsible for ensuring that products and processes meet established quality standards and customer requirements. Job Duties and Responsibilities Responsible for the Control Plans and GR&R for their respective areas. * Support FMEA development / updates as part of cross-functional team. * Perform root cause analysis and transform the analysis into the appropriate records, documents and communications for internal and external distribution, including corrective actions as part of a cross functional team. * Perform Measurement System Analysis including calibration records. * Address quality rejects and customer returned material. * Application of statistical techniques and assistance to others as required. * Monitor and help control scrap, including pareto and corrective action analysis. * Monitor, analyze and report on facility key indicators and associated improvement action plans. * Assist in supplier issues as required / needed. * Assist with process improvements and data analysis. * Support continuous improvement activities. * Conduct process capability studies and quality audits (LPA / CQI, Process). * Conduct customer visits and reviews. * Other duties as required. Skills Required: * Excellent organizational and time management skills. * Strong project management skills and leadership abilities. * Assertive and self-motivated. * Solid manufacturing background including Manufacturing, Engineering and Quality. * Ability to coordinate cross-functional activities. * Excellent communication (both written and oral) and interpersonal skills. * Excellent communication (both written and oral) in English. * Proficient in the use of MS Project, Excel, Word and PowerPoint. * Proficient in the understanding of Engineering drawings, GD&T, and technical specifications. * Good understanding of APQP and program management techniques. * Understanding of IATF requirements. * Understanding of Core Tools Requirements. * Understanding of and able to complete CQI Audits. Typical Experience Required/Preferred (include management experience or other specifics): * Associates degree or higher in Engineering, preferably in Quality, Industrial or Mechanical engineering with 4-7 years' experience required. o Work experience in lieu of degree will be considered. * ASQ Certified Quality Engineer, with experience in the automotive industry preferred. * Demonstrated competence in Quality related statistics. * Certified Quality Auditor for IATF-16949 preferred. * Experience with FMEA, Process Control Plans, Root Cause Analysis and Corrective Actions. * Exemplary interpersonal and communication skills, and the ability to work in a team environment. * SAP experience preferred * Understanding of IATF-16949 requirements * Understanding of Quality Core Tool requirements * Understanding of and able to complete CQI Audits * Must be capable of performing duties with limited supervision. Join our team of 40,000 problem solvers who are fostering a culture of innovation by leveraging the diverse perspectives of our global team. We believe in facing challenges head-on by finding opportunity and uncovering possibility, where roadblocks and barriers become targets instead of obstacles. We are One Dana with limitless opportunity. Our Values * Value Others * Inspire Innovation * Grow Responsibly * Win Together
    $61k-78k yearly est. 52d ago
  • Quality Engineer

    Denali Advanced Integration 3.4company rating

    Quality manager job in Garrett, IN

    Benefits: U.S.-based employees have access to medical, dental, and vision insurance, a 401(k) plan and company contribution, short-term and long-term disability coverage, basic life insurance, and wellbeing benefits, among others. U.S.-based employees also receive, per calendar year, up to 6 scheduled paid holidays. Additionally, eligible hourly/non-exempt and exempt employees accrue up to 112 hours of PTO based on years of service and may annually take up to 8 hours of paid volunteer time. Additional paid sick leave is also provided if required by state or local law. Summary of Position: The Quality Engineer supports the implementation and sustainment of Denali's Quality Management System and PLM processes. This role works closely with engineering, operations, and service delivery teams to monitor performance, drive root cause analysis, and implement corrective actions that ensure Denali's products and services meet customer and compliance requirements. Essential Functions: * Assist in implementing and maintaining Denali's QMS in alignment with ISO 9001 and customer-specific requirements * Support the integration of PLM capabilities, ensuring accurate control of drawings, BOMs, and change management across product and service lifecycles * Manage document control processes, including creation, revision, approval, and archival of SOPs, work instructions, and quality records * Maintain and update QMS documentation libraries, ensuring accessibility and compliance with revision standards * Collaborate with engineering, configuration, and operations teams to define inspection criteria, test plans, and acceptance procedures for incoming, in-process, and final products * Develop and implement process quality controls that ensure repeatability and consistency across Denali's global operations * Support Failure Mode and Effects Analysis (FMEA), process capability studies, and control plans for critical operations * Ensure calibration and maintenance of inspection tools and testing equipment used in configuration or production environments * Conduct process walk-throughs and line audits to validate adherence to SOPs and quality standards * Collect, analyze, and report on quality data, including defect rates, yield, RMA trends, first-pass success, and audit findings * Build and maintain dashboards to visualize quality performance across business units and identify trends requiring corrective action * Support the development and tracking of KPIs aligned with Denali's Quality Objectives and continuous improvement roadmap * Present data-driven insights to leadership during operational and management reviews to guide decision-making * Investigate product or service nonconformances through structured root cause analysis methodologies (5 Whys, Fishbone, Pareto, etc.) * Document, track, and verify closure of Corrective and Preventive Actions (CAPAs), ensuring timeliness and effectiveness * Support planning, scheduling, and execution of internal audits across all quality-critical processes * Assist in preparing documentation and objective evidence for third-party or certification audits (e.g., ISO 9001, customer audits) * Track and verify closure of audit findings and opportunities for improvement * Collaborate with Supply Chain to monitor supplier quality performance, including defect rates, on-time delivery, and RMA responsiveness * Support supplier onboarding and qualification processes by reviewing quality documentation and conducting remote or on-site evaluations * Identify opportunities for process and system improvement across Denali's operational ecosystem * Support training and communication initiatives to drive awareness and adoption of best practices * Contribute to post-project reviews by capturing lessons learned and quality performance outcomes * Provide training to internal teams on quality procedures, inspection techniques, and documentation requirements * Develop visual aids, job aids, and templates that support consistency across teams and functions Competencies: * Ensures Accountability * Tech Savvy * Communicates Effectively * Values Differences * Customer Focus * Resourcefulness * Drives Results * Plans and Prioritizes * Decision Quality * Self-Development Work Environment: This position is based in a professional office setting and regularly utilizes workplace technology, including computers, smartphones, multifunction printers, cloud-based filing systems, and collaboration tools. Physical Demands: This role requires physical capabilities that support the successful execution of key responsibilities. The employee regularly engages in verbal and written communication with colleagues and clients to address project-related inquiries and must be able to convey accurate information clearly and efficiently. The position involves remaining seated at a workstation for approximately 75% of the time, with occasional movement throughout the office to access equipment, supplies, and shared resources. Daily tasks include consistent use of computers and standard office technology such as keyboards, printers, and multifunction devices. The role also involves transporting equipment boxes weighing up to 25 pounds within the building and to other offsite locations as needed for project support. Required Education and Experience: * Bachelor's degree in Engineering, Quality, Industrial, or related technical field * 4-7 years of experience in quality engineering, process quality, or operational excellence in technology, manufacturing, or managed services Qualifications: * Working knowledge of ISO 9001 standards, audit practices, and CAPA systems * Proficiency in QMS/PLM or ERP systems (e.g., Propel, Arena, D365, or equivalent) * Strong analytical and statistical skills; experience with Excel, Power BI, or similar data tools for reporting and visualization * Familiarity with Lean Six Sigma principles (Green Belt or higher certification preferred) * Excellent communication, collaboration, and organizational skills * Experience supporting global or multi-site operations a plus AAP/EEO Statement: 3MD Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expression, veteran status or any other category that is protected by applicable law. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
    $63k-81k yearly est. 49d ago
  • Quality Coordinator

    Champagne Metals

    Quality manager job in Middlebury, IN

    Job Description Join Our Team as a Quality Coordinator - Where Precision Meets Passion Are you an organized, detail-oriented professional looking for a role where your skills can truly shine? If you have quality coordinator experience and a keen eye for detail apply now! Pay: $18-$21 per hour (or more with experience - let's talk!) Shifts: 1st What You'll Do: -Take initiative - Inspect materials during production to ensure top-notch quality. - Review and complete claim forms for rejected materials. - Use tools such as tape measures, micrometers, and calipers to inspect and measure materials. - Confidently inspect questionable materials and make sound decisions. - Leverage basic Microsoft Office skills to keep everything on track. - Outlook for emails. What You Bring: - Quality control experience. - Ability to work independently with minimal supervision. - Strong attention to detail and a passion for precision. Why Champagne Metals? At Champagne Metals, we're more than just a company - we're a family. We value our employees and demonstrate this with amazing benefits: - Paid Time Off: 15 days of PTO in your first year. - 401(K) Matching: We match 5% to help you secure your future. - Health Coverage: Premiums paid by us, including Blue Cross Blue Shield health insurance. - Supportive Team: A quality-driven culture where your work truly matters. If you're ready to make an impact and grow with a company that values you, apply today! Your next career adventure awaits.
    $18-21 hourly 11d ago
  • Quality Coordinator - 2nd Shift

    Avancez

    Quality manager job in Roanoke, IN

    Quality Coordinator is responsible for completing and performing tasks in support to deliver zero defects in the build and assembly processes. They support the goals of customer satisfaction by supporting or leading problem solving on the floor, coaching and training team members in quality topics, and support operations with addressing any quality concerns. DUTIES AND RESPONSIBILITIES: Complete work in a safe manner and help the site maintain safety standards. Provides support through communicating quality status to the team and the managers, facilitating the setting of quality goals and provides the necessary training to continually improve Android/Avancez's quality. Responsible for performing quality control inspections, checks, and tests during the assembling process including materials, parts, and product at different stages of production ensure compliance to customer requirements. Responsible to support and assist in different layers of audits at the site (internal, external, layered process audits, etc).Identify gaps, work with a team to solve concern, and report out to management on results. Make customer plant visits to investigate quality performance, and process customer returns. Evaluate materials to quality requirements, identify supplier defects, internal defects, and report out to the management team. Maintain quality test data files and runs quality related reports. All other duties as assigned. EDUCATION AND EXPERIENCE: High School Diploma or Equivalent. Years of Experience: 3+ years of Quality control experience and at least 1 year in an automotive manufacturing/assembly environment. KNOWLEDGE, SKILLS, AND ABILITIES: Knowledge of ISO9001 or IATF 16949:2016 Quality Systems. Committed to achieving world class performance standards. Sense of urgency and an overall customer satisfaction focus. Great interpersonal and communication skills. Ability to collaborate across different stakeholders. Excellent time management skills and ability to multi-task in a fast paced, short-window automotive assembly and/or sequencing plant environment. Basic math and computer skills. Production system and module product knowledge. Error proofing knowledge.
    $46k-73k yearly est. 4d ago
  • Quality Coordinator - 2nd Shift

    Voltava

    Quality manager job in Roanoke, IN

    Quality Coordinator is responsible for completing and performing tasks in support to deliver zero defects in the build and assembly processes. They support the goals of customer satisfaction by supporting or leading problem solving on the floor, coaching and training team members in quality topics, and support operations with addressing any quality concerns. DUTIES AND RESPONSIBILITIES: Complete work in a safe manner and help the site maintain safety standards. Provides support through communicating quality status to the team and the managers, facilitating the setting of quality goals and provides the necessary training to continually improve Android/Avancez's quality. Responsible for performing quality control inspections, checks, and tests during the assembling process including materials, parts, and product at different stages of production ensure compliance to customer requirements. Responsible to support and assist in different layers of audits at the site (internal, external, layered process audits, etc).Identify gaps, work with a team to solve concern, and report out to management on results. Make customer plant visits to investigate quality performance, and process customer returns. Evaluate materials to quality requirements, identify supplier defects, internal defects, and report out to the management team. Maintain quality test data files and runs quality related reports. All other duties as assigned. EDUCATION AND EXPERIENCE: High School Diploma or Equivalent. Years of Experience: 3+ years of Quality control experience and at least 1 year in an automotive manufacturing/assembly environment. KNOWLEDGE, SKILLS, AND ABILITIES: Knowledge of ISO9001 or IATF 16949:2016 Quality Systems. Committed to achieving world class performance standards. Sense of urgency and an overall customer satisfaction focus. Great interpersonal and communication skills. Ability to collaborate across different stakeholders. Excellent time management skills and ability to multi-task in a fast paced, short-window automotive assembly and/or sequencing plant environment. Basic math and computer skills. Production system and module product knowledge. Error proofing knowledge.
    $46k-73k yearly est. 4d ago
  • Quality Engineer

    Weg Sa 3.3company rating

    Quality manager job in Bluffton, IN

    Founded in 1961, WEG has grown into a global solutions provider of industrial electrical technologies. WEG is the largest industrial electric motor manufacturer in the Americas and one of the largest manufacturers of electric motors in the world producing more than 21 million units annually. Committed to growth on a global scale, WEG continually invests in state-of-the-art manufacturing facilities and processes and the development of new and improved industrial electrical solutions. WEG offers a diverse and integrated product line that includes motors, drives, soft starters, controls, panels, transformers, generators, and custom solutions. Position Overview The Quality Engineer is responsible for acting in the interest of quality assurance of our products and processes, performing problem-solving project coordination involving multi-departmental areas, developing inspection plans and corrective action plans related to internal and external failures. The Quality Engineer's focus is on reducing the Quality KPIs (Field Failures and Non-Quality Costs) to drive long term results. Main Responsibilities Implement all relevant procedures described in the Quality System. Work on samples and pilot batches reviewing quality standards. Oversee the main quality KPIs and develop action plans related to any undesirable results. Coordinate quality investigations, develop reports, and lead associated corrective actions. Visit customer sites to evaluate our product performance and application (when necessary). Oversee the technician activities providing guidance and coaching on proper tool usage. Enforce customer/supplier philosophy throughout the plant. Audit the plant critical processes periodically, identifying weak points and suggesting possible solutions. Establish an effective working relationship with all supporting areas (Engineering, Purchasing, Manufacturing, Etc.) to increase cross-functional collaboration and problem solving. Participate in the analysis of customer returned products whenever necessary. Requirements Qualifications Bachelor's Degree in an engineering discipline required. Experience may be considered in lieu of degree. Previous experience in quality engineering capacity or similar strongly preferred. Familiarity with lean and six sigma tools strongly preferred. Six Sigma Green Belt or greater is strongly desired. Familiarity with manufacturing processes and ERP systems; Prior SAP Experience preferred Experience with quality investigations and the use of 8D reports Strong working knowledge of office tools including; Word, Excel, and PowerPoint is essential. Strong analytical and problem-solving skills required. Excellent communication and interpersonal abilities required. Demonstrated troubleshooting skills required. Must be eager to learn new technologies and techniques. Must be able to frequently sit and/or stand for long periods of time.
    $61k-83k yearly est. 60d+ ago
  • Supplier Quality Engineer

    Insight Global

    Quality manager job in Warsaw, IN

    The candidate will be working on the following: - Review Approved Supplier List, update as needed - Review Supplier Quality Agreements, update as needed. - Review supplier capabilities and identify any risks. - Drafting, communicating, and own Process Verification/Validation plans and reports - Review and identify gaps in supplier special process validations. - Coordinating with suppliers to complete open actions - Resolve supplier nonconformances - Hold supplier accountable for deliverables, corrections, and status updates We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements The candidate will be working on the following: - Review Approved Supplier List, update as needed - Review Supplier Quality Agreements, update as needed. - Review supplier capabilities and identify any risks. - Drafting, communicating, and own Process Verification/Validation plans and reports - Review and identify gaps in supplier special process validations. - Coordinating with suppliers to complete open actions - Resolve supplier nonconformances - Hold supplier accountable for deliverables, corrections, and status updates
    $63k-81k yearly est. 2d ago
  • Quality Engineer

    360 It Professionals 3.6company rating

    Quality manager job in Warsaw, IN

    360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description This position is expected to support key post market quality efforts within orthopedic business units, including, but not limited to o Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. o Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. o Formulates procedures, specifications, and standards for Zimmer products and processes. o Collects and analyzes data for product evaluation. o Performs product issue investigations from initiation, risk evaluation, result reporting, and closure. Qualifications Expected Areas of Competence o Ability to deliver, meet deadlines and have results orientation. o Demonstrates characteristics of high potential for future development opportunities. o Basic knowledge of blueprint reading and geometric dimensioning and tolerancing, familiarity with QSR/ISO regulations, design assurance, FMEA, and product testing methods. o B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE). o Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred. o Bachelors degree in sciences, health care certificates, mechanical or biologic chemistry, or biomedical engineering, or related field and a minimum of 2 years of related experience. Additional Information All your information will be kept confidential according to EEO guidelines. Please contact Shilpa Sood @ 510-254-3300 Ext 183
    $63k-80k yearly est. 1d ago
  • Quality Engineer

    Masterbrand Cabinets 4.6company rating

    Quality manager job in Goshen, IN

    For nearly 70 years, MasterBrand has been shaping the places where people come together, enriching lives and creating meaningful memories for our customers. That, combined with our stylish products, expansive dealer and retail network, and dedicated associates, has helped make us the number one North American residential cabinet business. Our unique culture of continuous improvement is based on trusting the tools, empowering the team and moving forward, and is kept alive by our more than 10,000 associates across 20 plus manufacturing facilities and offices. Visit ******************* to learn more and join us in building great experiences together. Job Description The Quality Engineer works within the MasterBrand Quality System, using analysis and statistical techniques, to assist in the continual improvement of the manufacturing processes. This individual will also assist in solving problems, controlling variables, and providing candid and accurate feedback that are critical to quality. Knowledge, Skills, and Experience Ability to apply and interpret statistical data Computer skills (Word, Excel, and PowerPoint) required Six Sigma training and experience preferred, specifically experience in PFEMA Must be a team player with strong written and verbal communication skills Must have the ability to actively initiate, lead and participated in problem solving activities Must be able to give candid feedback and report findings of non-compliance to the Goshen Quality System Ability to maintain the professional competence, knowledge, and skill necessary for the satisfactory performance of all assigned responsibilities Must have the ability to deliver a formal project status presentation to MasterBrand Leadership. Characteristics & Attributes Ensures accountability; holds self and others accountable to meet commitments Drives result; consistently achieve results, even under tough circumstances Communicate effectively; develop and deliver multi-mode communications that convey a clear understanding of the unique needs of different audiences Instills trust; gains the confidence and trust of others through honesty, integrity, and authenticity Collaboration; works cooperatively with others across the organization to achieve shared objectives Directs work; provides clear direction and accountabilities Drive engagement; creating a climate where people are motivated to do their best to help the organization achieve its objectives Persuades; use compelling arguments to gain the support and commitment of others Being resilient; rebound from setbacks and adversity when facing difficult situations Organizational Relationship This position reports directly to the Quality Manager. Qualifications BS degree in Industrial or Mechanical Engineering or equivalent Strong analytical, problem solving, delegation and conflict resolution skills Strong written and verbal communication skills 3-6 years of quality experience in manufacturing preferred Additional Information Equal Employment Opportunity MasterBrand Cabinets LLC is an equal opportunity employer. MasterBrand Cabinets LLC's policy is not to discriminate against any applicant or employee based on race, color, religion, sex, gender identity or expression, national origin, ancestry, age, disability/handicap status, marital status, military status, sexual orientation, genetic history or information, or any other basis protected by federal, state or local laws. MasterBrand Cabinets LLC also prohibits harassment of applicants or employees based on any of these protected categories. It is also MasterBrand Cabinets LLC's policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Reasonable Accommodations MasterBrand Cabinets LLC is committed to working with and providing reasonable accommodations to individuals with disabilities. If you have a disability and wish to discuss potential accommodations related to applying for employment, please contact us at [email protected].
    $56k-68k yearly est. 60d+ ago
  • Associate Director - QA

    Eli Lilly and Company 4.6company rating

    Quality manager job in Gas City, IN

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. The Associate Director is a member of the Quality Assurance Compliance organization. The purpose of the Associate Director role is to support the development and implementation of the Indianapolis Active Pharmaceutical Ingredient (IAPI) Quality Management System (QMS) and its elements across the site. This includes end-to-end process ownership, oversight and execution of QMS deliverables throughout the QMS life cycle to ensure CGMP compliance with local, global, regulatory and industry requirements. This role collaborates with quality and other site functions to integrate these requirements into the manufacturing operations and support areas. Responsibilities: Assume end-to-end process ownership and oversight of QMS elements at the site (e.g. change management, deviation management, inspection readiness, pharmacovigilance) Provide coaching, mentoring, training and technical expertise to the site as the Subject Matter Expert (SME) for any given QMS process Tabulate and facilitate metrics reporting to the Site Lead Team and for monitoring and continuous improvement of the QMS processes Provide support for internal and external audits/inspections (e.g. readiness, back/front room support, coordination of inspection responses) Lead and/or participate in the site Inspection Readiness Team and its initiatives Provide QA support to local regulatory and global affiliates for GMP certification registrations, renewals and submissions Stay abreast of latest trends, applications, and compliance requirements. Share trends at site applicable forums and establish strategies/actions for deployment when applicable Participate in management review activities of the global quality systems Contribute to the development of area specific procedures and supporting documents (e.g. required tools, resource documents and supplemental materials) Review and approve quality system related documents Basic Requirements: Bachelor's Degree in a science/technology/health care related field 5+ years of CGMP pharmaceutical experience Additional Preferences: Previous QA/QC experience in a CGMP environment Demonstrated ability to communicate effectively, both written and verbal, and to influence others Demonstrated ability to prioritize and handle multiple tasks concurrently Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies Previous experience leading and implementing projects at a site level is preferred Experience in pharmacovigilance Ability to present information and concepts at all levels of the organization Additional Information: No certifications required Tasks may require entering manufacturing areas which require wearing appropriate PPE and adherence to local safety guidelines After-hours and weekend support may be required as necessary Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $187,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $115.5k-187k yearly Auto-Apply 1d ago
  • Quality Coordinator

    Champagne Metals

    Quality manager job in Middlebury, IN

    Join Our Team as a Quality Coordinator - Where Precision Meets Passion Are you an organized, detail-oriented professional looking for a role where your skills can truly shine? If you have quality coordinator experience and a keen eye for detail apply now! Pay: $18-$21 per hour (or more with experience - let's talk!) Shifts: 1st What You'll Do: -Take initiative - Inspect materials during production to ensure top-notch quality. - Review and complete claim forms for rejected materials. - Use tools such as tape measures, micrometers, and calipers to inspect and measure materials. - Confidently inspect questionable materials and make sound decisions. - Leverage basic Microsoft Office skills to keep everything on track. - Outlook for emails. What You Bring: - Quality control experience. - Ability to work independently with minimal supervision. - Strong attention to detail and a passion for precision. Why Champagne Metals? At Champagne Metals, we're more than just a company - we're a family. We value our employees and demonstrate this with amazing benefits: - Paid Time Off: 15 days of PTO in your first year. - 401(K) Matching: We match 5% to help you secure your future. - Health Coverage: Premiums paid by us, including Blue Cross Blue Shield health insurance. - Supportive Team: A quality-driven culture where your work truly matters. If you're ready to make an impact and grow with a company that values you, apply today! Your next career adventure awaits.
    $18-21 hourly 9d ago
  • Quality Engineer

    360 It Professionals 3.6company rating

    Quality manager job in Warsaw, IN

    360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description This position is expected to support key post market quality efforts within orthopedic business units, including, but not limited to o Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. o Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. o Formulates procedures, specifications, and standards for Zimmer products and processes. o Collects and analyzes data for product evaluation. o Performs product issue investigations from initiation, risk evaluation, result reporting, and closure. Qualifications Expected Areas of Competence o Ability to deliver, meet deadlines and have results orientation. o Demonstrates characteristics of high potential for future development opportunities. o Basic knowledge of blueprint reading and geometric dimensioning and tolerancing, familiarity with QSR/ISO regulations, design assurance, FMEA, and product testing methods. o B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE). o Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred. o Bachelors degree in sciences, health care certificates, mechanical or biologic chemistry, or biomedical engineering, or related field and a minimum of 2 years of related experience. Additional Information All your information will be kept confidential according to EEO guidelines. Please contact Shilpa Sood @ 510-254-3300 Ext 183
    $63k-80k yearly est. 60d+ ago

Learn more about quality manager jobs

How much does a quality manager earn in Fort Wayne, IN?

The average quality manager in Fort Wayne, IN earns between $52,000 and $126,000 annually. This compares to the national average quality manager range of $64,000 to $128,000.

Average quality manager salary in Fort Wayne, IN

$81,000

What are the biggest employers of Quality Managers in Fort Wayne, IN?

The biggest employers of Quality Managers in Fort Wayne, IN are:
  1. Holder Construction
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